A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and PK of HPN217 in Patients With R/R MM

For people ages 18-100

Major Inclusion Criteria:

1. Received at least 3 prior therapies (including proteasome inhibitor, immune modulatory drug, and an anti-CD38 antibody; patients should not be a candidate for or be intolerant of all established therapies known to provide clinical benefit in multiple myeloma).
2. Measurable disease defined as at least one of the following:
3. Serum M-protein ≥0.5 g/dL
4. Urine M-protein ≥200 mg/24 hours
5. Serum free light chain (FLC) assay: Involved FLC level ≥10 mg/dL (≥100 mg/L)
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
7. Adequate hematologic status, including:
8. Absolute neutrophil count (ANC) ≥1000 cells/μL
9. Platelet count ≥50,000/μL (without transfusions)
10. Hemoglobin ≥8 g/dL
11. Adequate renal function, including:
12. Calculated creatinine clearance ≥30 mL/min using the formula of Cockcroft and Gault
13. Adequate hepatic function, including
14. Total bilirubin ≤1.5 × upper limit of normal (ULN), regardless of direct bilirubin
15. AST and ALT ≤3.0 × ULN (≤5.0× ULN if due to myeloma involvement)
16. Alkaline phosphatase ≤3× ULN (≤5.0× ULN if due to myeloma involvement)

Major Exclusion Criteria:

1. Prior exposure to BCMA-targeting agents (Part 2 only)
2. Concurrent treatment with anti-tumor necrosis factor alpha therapies, systemic corticosteroids (prednisone dose >10 mg per day or equivalent), or other immune suppressive drugs within the 2 weeks prior to Screening